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Dosage form: & nbspGranules for solution for oral administration
Composition:1 packet of granules contains
Active substances:
Ribosomal fractions: 0.75 mg
(in terms of ribosomal RNA - 0.525 mg)
Klebsiella pneumoniae - 3.5 shares
Streptococcus pneumoniae -3.0 share
Streptococcus pyogenes - 3.0 shares
Haemophilus influenzae - 0.5%
Membrane fraction: 1.125 mg
Klebsiella pneumoniae - 15 shares
Excipients:
povidone - 10 mg,
mannitol up to 500 mg
Description:The granules are white in color, odorless.
Pharmacotherapeutic group:Immunostimulating agent of bacterial origin.
ATX: & nbsp
  • Other immunostimulants
  • Pharmacodynamics:Ribomunil promotes the development of a specific and nonspecific immune response to infection of the ENT organs, which leads to the development of antibacterial and anti-viral immunity.
    In studies, immunogenic and immunomodulating properties of the Ribomunil preparation were detected, which indicates the ability of the drug to penetrate the intestinal mucosa. The membrane fraction of Klebsiella pneumoniae, which is part of the preparation, interacts with the receptors of the immune system cells, which ensure the development of innate immunity. These receptors, expressed by the cells of the innate immunity system, cause a wide range of activity of the Ribomunyl preparation against a non-specific immune response, namely, an increase in the functional activity of neutrophils (adhesion and migration), activation of monocytes / macrophages and natural killers.Ribomunyl also induces the maturation of human dendritic cells, which leads to the stimulation of T cell proliferation, which causes a specific immune response to the ribosomal fractions of the preparation.
    Structural-biochemical characteristics shows the presence of macromolecules on ribosomes, the corresponding antigens, usually expressed on the walls of bacterial cells. Each ribosomal fraction is immunogenic due to the close interaction of ribosomal macromolecules and RNA, and acts as an antigen of the vaccine, resulting in the appearance of specific cells secreting antibodies in the blood and mucous membranes. These cells locally produce specific antibodies that are able to recognize the antigens of the whole bacterial cell and reduce the adhesion of bacteria to the epithelial cells.
    Pharmacokinetics:Ribomunil has good bioavailability and reaches Peyer's patches of the intestine, where it stimulates immunocompetent cells.
    The macromolecules that are part of the Ribomunil preparation are not subjected to any special metabolism, so it is unlikely that the drug will enter into drug interactions.
    Indications:Prevention of recurrent ENT infections in adults and children over 2 years of age.
    Contraindications:-increased sensitivity to the components of the drug;
    -Autoimmune diseases;
    - Acute intestinal infection;
    -Children under 2 years old.
    Carefully:Patients with bronchial asthma may have an exacerbation of the disease by taking immunostimulants containing bacterial components. When developing an asthmatic attack or a hypersensitivity reaction, the drug should be immediately withdrawn. Renew his reception in the future should not be.
    Pregnancy and lactation:Special studies on the use of Ribomunil in pregnancy and during breastfeeding are not
    was conducted. The use of Ribomunil during pregnancy and during breast-feeding is recommended to be avoided.
    Dosing and Administration:Inside.
    Adults and children over 2 years - once a day on an empty stomach. Single dose: 1 packet with granules (granules pre-dissolve in boiled water at room temperature). In the first month, the drug Ribomunil is taken daily for the first 4 days of each week, for 3 consecutive weeks; in the next 2-5 months: the first 4 consecutive days of each month.
    Side effects:Adverse reactions are systematized according to the system-organ classes and are listed according to the following gradation:
    very often (≥1 / 10), 1
    often (≥1 / 100 to <1/10),
    infrequently (≥1 / 1000 to <1/100),
    rarely (≥1 / 10000 to <1/1000),
    very rarely (<1/10000),
    frequency is unknown (can not be estimated from available data).
    Infectious and parasitic diseases
    Often: rhinopharyngitis, tonsillitis, ear infections.
    Infrequently: sinusitis, bronchitis, gastroenteritis.
    Frequency unknown: laryngitis.
    Violations of the blood and lymphatic system
    Infrequent: lymphadenopathy.
    Immune system disorders
    The frequency is unknown: hypersensitivity, urticaria, angioedema.
    Disturbances from the respiratory system, chest and mediastinal organs
    Infrequently: cough.
    The frequency is unknown: bronchial asthma.
    Disorders from the gastrointestinal tract
    Infrequently: nausea, vomiting, diarrhea and abdominal pain, hypersalivation.
    Disturbances from the skin and subcutaneous tissues
    The frequency is unknown: eczema, simple and nodosum erythema, vascular purpura.
    General disorders and disorders at the site of administration
    Infrequently: pyrexia, asthenia.
    Overdose:There were no significant adverse reactions in case of drug overdose.
    Interaction:Until now, interaction with other drugs has not been established.
    Special studies on the interaction of the drug Ribomunil with other drugs are not was conducted.
    Special instructions:A significant increase in body temperature (≥39 ° C) of unknown origin is possible, in which case the drug intake should immediately stop and resume its reception in the future should not be.
    This phenomenon should not be confused with the transient rise in body temperature, which is sometimes observed at the beginning treatment and may be accompanied by minor and transient symptoms of infections from the ENT organs and, as a rule, does not require withdrawal of the drug.
    Form release / dosage:Granules for the preparation of solution for oral administration 0,75 mg.
    Packaging:For 500 mg per bag of laminated paper / aluminum foil / polyethylene.
    For 4 bags together with instructions for use in a cardboard box.
    Storage conditions:At a temperature not exceeding 30 ° C.
    Keep out of the reach of children.
    Shelf life:3 years.
    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011369 / 02
    Date of registration:27.04.2010 / 18.02.2013
    The owner of the registration certificate:Pierre Fabre Medication ProductionPierre Fabre Medication Production France
    Manufacturer: & nbsp
    Representation: & nbspPIER FABR PIER FABR France
    Information update date: & nbsp2016-02-05
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